Kornimate/medical-research-clean huggingface dataset:
a study of the effect of biib023 on muscle atrophy in healthy male volunteers

Conditions: Healthy

Summary: the primary objective of this study is to determine whether muscle atrophy induced by immobilization of the lower limb can be attenuated by biib023 in healthy male volunteers. the secondary objectives of this study in this study population are: * to determine whether muscle weakness induced by immobilization of the lower limb can be attenuated by biib023 * to assess the effect of biib023 on the recovery of muscle mass and strength after immobilization * to assess the effect of biib023 on histological markers of muscle atrophy and regeneration * to assess the effect of biib023 on muscle bioenergetics based on oxidative metabolism recovery kinetics * to evaluate the safety and tolerability of biib023


Eligibility criteria:
key inclusion criteria: * deemed healthy as determined by the investigator based on medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters at screening, and physical examination at baseline * body mass index (bmi) between 18.5 and 32 kg/m2, inclusive, at the time of screening * willing to abstain from using tobacco and tobacco-containing products during the study * willing to limit the intake of alcohol to no more than 2 units per day throughout the study; exceptions are 48 hours prior to screening, 48 hours prior to day 1, and during the in-clinic immobilization period when no alcohol will be permitted. one unit of alcohol is defined as 12 fluid ounce (fl oz) of beer, 5 fl oz of wine, or 1.5 fl oz of liquor * willing to maintain a regular diet for the duration of the study and a recreational level of physical activity defined as participation in an exercise program or other physical activity at a level of intensity that does not exceed the level prior to study entry * practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after the last dose of study treatment. key exclusion criteria: * history of or positive test result at screening for human immunodeficiency virus (hiv). * history or positive test result at screening for hepatitis c virus (hcv) antibody or hepatitis b virus (defined as positive for hepatitis b surface antigen \[hbsag\] or hepatitis b core antibody \[hbcab\]). * history of tuberculosis (tb) or a positive quantiferon®-tb gold test. there must be no other clinical evidence of tb on physical examination of the subject. * use of tobacco or tobacco-containing products within 3 months prior to screening * known history of thrombophilia, hypercoagulopathy, or prior history of deep vein thrombosis (dvt) or pulmonary embolism (pe) * history of physical activity consistent with endurance training or resistance training within 6 months prior to screening * any back, leg, knee, or shoulder complaints that may interfere with the use of crutches * prolonged travel (more than 6 hours) within 2 weeks prior to randomization. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: muscle disuse atrophy
pharmacokinetics of zsp1273 in participants with hepatic impairment

Conditions: Hepatic Impairment; Pharmacokinetics

Summary: this study will assess the effect of hepatic impairment on the pharmacokinetics (pk), safety and tolerability of zsp1273.


Eligibility criteria:
inclusion criteria: 1. participant must be ≥ 18 to ≤ 68 years, at the time of signing the informed consent. 2. bmi ≥ 18 kg/m2 up to ≤ 32 kg/m2. 3. participants (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product. 4. signature of a dated informed consent form (icf) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment. participants with hepatic impairment only: 5. supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available. 6. unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening, or treatment-naïve participants exclusion criteria: 1. participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product. 2. qtcf (male) \> 470ms，qtcf (female) \> 480ms 3. participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks 4. participants who donated blood or bleeding profusely (\> 400 ml) in the 3 months. 5. pregnant or lactating women, or women of childbearing age with a positive pregnancy test 6. smoking averaged more than 10 cigarettes per day in the 3 months prior to screening participants with normal hepatic function only: 7. any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening. participants with hepatic impairment only: 8. any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratoryor hematological, immune, psychiatric, and metabolic disorders. 9. participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices
effect of sensory integration therapy on balance and functional mobility

Conditions: Cerebral Palsy

Summary: purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. balance was assessed using the biodex balance system and functional mobility was assessed using the timed up and go test.

purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. balance was assessed using the biodex balance system and functional mobility was assessed using the timed up and go test. the control group received selected physical therapy, while the study group received the previously mentioned selected physical therapy program modified to increase sensory input. treatment sessions for both groups were conducted for both groups for 1 hour once a day, three times per week for two successive months.

Eligibility criteria:
inclusion criteria: ages from 6-10 years old. the degree of spasticity was 1 to 1+ level ii according to the gross motor function classification system exclusion criteria: visual or auditory problems. fixed deformities of lower limbs.
levofloxacin-doxycycline for helicobacter pylori eradication in saudi arabia

Conditions: GASTRITIS

Summary: helicobacter pylori (h. pylori) eradication is achieved in 60-80% with first-line therapy. different second-line therapeutic options are available. however, the success of second-line therapy has not been addressed or reported from saudi arabia. objectives the primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for h. pylori eradication in saudi arabia. secondary objectives included; symptoms response to treatment, factors associated with eradication of h. pylori and adverse events associated with the treatment.

a prospective, open-label, single arm study was conducted. patients were recruited from a tertiary care hospital in saudi arabia from june 2013 to april 2014. a total of 55 patients had previously received standard triple therapy and/or sequential therapy in the period from 2011 to 2014 and failed to eradicate the infection. the rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily. urea-breath-test (ubt) was done at a minimum of 6 weeks after completion of the treatment to confirm the h. pylori eradication. compliance and tolerability of the regimen were also assessed.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * received previous treatment with triple therapy, sequential therapy or both * has evidence of persistence h. pylori infection by a positive urea breath test (ubt), histology or rapid urease test (hp fast. gi supply™, pa, usa) exclusion criteria: * previously treated with quadruple or levofloxacin-based therapy * had an allergy to doxycycline, levofloxacin or esomeprazole * pregnant or lactating * significant hepatic, renal, or cardiopulmonary disorders, or active malignancy.
barriers to patients' early presentation, diagnosis and treatment in childhood hydrocephalus

Conditions: Hydrocephalus in Children

Summary: patient with childhood hydrocephalus (hc) tend to present late in low medium income countries (lmics). this project will study the barriers leading to patients' and health system delay in patients with childhood hc. this will be done via a quantitative and qualitative study analysis. the data will be collected prospectively.

children less than 5 years of age with hc confirmed with either magnetic resonance or computerized tomographic images will be recruited. in addition, hospital staff members, who have been working within the neurosurgical unit for at least 5 years will be interviewed. the patients' data that will be collected will include gender, age at presentation, socioeconomic class of parents (or guardians), religion, referral source, presenting complaint with its duration, physical findings, ventricular diameter. the pre-presentation symptoms interval (ppi) will be defined as the number of days between the onset of symptoms and first presentation at any type of healthcare service centre (including primary healthcare centre, secondary health institutions); presentation interval (pi)- number of days from symptoms to presenting at neurosurgical centre; pre-diagnostic interval (pdi) will be defined as the interval in days between symptoms and completion of pre-operative investigations. patient interval (pi) will be defined as the number of days from the onset of symptoms and patient's first contact with the neurosurgical center. hospital interval (hi)- number of days from completion of investigations to surgical intervention. the collected data will be analyzed according to qualitative conventional content analysis. nvivo software version 13 and statistical product and service solutions (spss) version 23 will be used for data analysis.

Eligibility criteria:
inclusion criteria: * all patients less than 5 years of age with hc confirmed with either magnetic resonance or computerized tomographic images * patients' parents' inclusion criteria will be parents (guardians) of children with radiologically confirmed hc with either magnetic resonance or computerized tomographic images. * hospital staff members, who have been working within the neurosurgical unit for at least 5 years. exclusion criteria: * all patents not investigated or operated at our centre * patients older than 5 years
tnf-alfa inhibitors and antibody production in patients with psoriasis

Conditions: Psoriasis

Summary: tnf alfa blockers are widely used for treatment of severe psoriasis. these biologics are well-tolerated with few side effects. unfortunately not all patients respond adequately to treatment with tnf alfa blockers. some do not respond at all while others respond initially but gradually lose effect despite increased dose and more frequent administration. the cause of treatment failure is largely unknown and it may be production of tnf-alfa neutralizing antibodies. this has been demonstrated in patients with rheumatoid arthritis and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.


Eligibility criteria:
inclusion criteria: * male or female * age above 18 * psoriasis * indication for treatment with tnf alfa blocking drug * written informed consent obtained exclusion criteria: * severe psychiatric disorder * no indication for treatment with tnf-alfa blocking drug * pregnancy * breastfeeding * no written informed consent

Keywords: psoriasis treatment failure tnf-alfa
pd-1 antibody in addition to bace in patients with nsclc: a randomised controlled trial

Conditions: NSCLC

Summary: this is a randomized controlled trial to determine the efficacy and safety of pd-1 antibody in addition to bronchial arterial chemoembolization in stage iii-ⅳ nsclc patients who failed, refused or ineligible to receive standard treatments.

bronchial artery chemoembolization (bace) is a technique of drug delivery and embolization performed via injecting anti-tumor drugs with drug carriers and implanting the embolization agents into the tumor feeding artery, promoting the clinical outcomes of patients and providing a palliative treatment option for patients with nsclc. while the short-term effect of bace is good, it is easy to relapse and metastasize. the rapid development of immunotherapy checkpoint inhibitors represented by pd-1/l1 monoclonal antibody has changed the treatment pattern of nsclc. the publication of early research data repeatedly verified the long-term survival benefit characteristics of pd-1/l1 in nsclc. based on this research and clinical practice, we designed this trial to determine the efficacy and safety of pd-1 antibody in addition to bronchial arterial chemoembolization in stage iii-ⅳ nsclc patients who failed, refused or ineligible to receive standard treatments.

Eligibility criteria:
inclusion criteria: 1. patient age between 18 and 75 2. signed informed consent form. 3. confirmed tnm stage is iii-ⅳ of nsclc ，and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, chemotherapy )； eastern cooperative oncology group (ecog) performance status ≤ 1 4. adequate hematologic and end-organ function. 5. expected life span \> 3 months. 6. be able to provide fresh or archival tumor tissues for pd-l1 expression in tumor cells exclusion criteria: 1. prior treatment targeting pd-1, pd-l1 or ctla-4. 2. prior therapies of interventional therapy (i seed implantation, ablation, bace). 3. harboring egfr sensitizing mutation or alk gene translocation 4. history of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline. 5. with uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment. 6. symptomatic central nervous system metastasis 7. known hiv infection, participants with untreated chronic hepatitis b, active vaccination treatment. 8. prior allogeneic stem cell transplantation or organ transplantation 9. active autoimmune diseases or history of autoimmune diseases that may relapse. 10. with conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications 11. known to be hypersensitive to contrast agent; 12. pregnant or breastfeeding women; 13. other protocol defined inclusion/exclusion criteria may apply

Keywords: bace pd-1 antibody
control of the opening of mptp by ex vivo measurements on permeabilized muscle fibers (commef)

Conditions: Anterior Cruciate Ligament Injuries

Summary: mptp (mitochondrial permeability transition pore) is a channel formed by a protein complex integrated into the inner membrane of mitochondria. its opening is related to the elevation of the intra-mitochondrial calcium concentration and will result in: a mitochondrial decoupling, a rupture of the metabolic gradient and the release of pro-apoptotic factors. the objective of this study is the development of a new ex vivo technique for characterizing mptp by a dual measurement combining oxygraphy and fluorimetry on permeabilized skeletal muscle fibers.

the development of new expertise in the study of mptp is part of an approach to optimize the processing of muscle samples. the aim of this work is to evaluate the feasibility and reproducibility of a method of analysis on muscle fibers only permeabilized, while coupling two complementary techniques, oxygraphy and fluorimetry. its principle is based on the knowledge that the opening of the mptp leads to an inhibition of respiration at the level of the complex i of the respiratory chain. this inhibition is the consequence of the escape from mitochondria of the reduced form of nicotinamide adenine dinucleotide (nadh, i.e. substrate of complex i) concomitant with the opening of mptp. thus, the oxygraphy must allow the observation of the inhibition of respiration synonymous with the non-availability of the substrate of the complex i and thus indirectly reflect the opening of the mptp. for its part, the fluorimetry must allow, in the presence of a fluorescent calcium indicator (i.e. calcium green), the observation of the release of calcium synonymous with the opening of the mptp. once validated, this technique should make it possible to evaluate in situ the sensitivity of mptp to calcium. in a context of application within clinical protocols, the evaluation of the mptp calcium sensitivity should contribute to a better understanding of the physiological and physio-pathological mechanisms of adaptation of muscle tissue.

Eligibility criteria:
inclusion criteria: * patients aged over 18 ; * patients referred for a knee ligamentoplasty (didt technique) ; * patients who signed the non-opposition form after being informed ; * patients benefiting from or affiliated to a social security. exclusion criteria: - patients under guardianship, curatorship or deprived of liberty.

Keywords: anterior cruciate ligament operation skeletal muscle mitochondria calcium mitochondrial permeability transition pore opening (mptp opening)
effect of myofascial release on scoliotic females with dysmenorrhea.

Conditions: Scoliosis Idiopathic Adolescent; Dysmenorrhea; Premenstrual Syndrome; Quality of Life

Summary: purpose: the purpose of this study is to determine the effect of myofascial release on spinal curvature, premenstrual symptoms, and quality of life in scoliotic females with dysmenorrhea

adolescent idiopathic scoliosis (ais) is a complex 3d structural disorder of the spine seen in children from 10 years old until skeletal maturity and confirmed by a cobb angle of 10° or more and accompanied by vertebral rotation (addai et al., 2020). it is the most common types of scoliosis and it is predominantly seen in girls at low curve magnitudes ( lebauer et al., 2008). a previous study reported the beneficial effect of myofascial release (mfr) on adults with idiopathic scoliosis (lebauer et al., 2008). mfr showed a decrease in pain, improved posture, and advancement in quality of life, which may include physical, social, and pulmonary function (las penas, 2005). hypotheses: there will be no effect of myofascial release on spinal curvatures, menstrual pain, and quality of life in young scoliotic females with primary dysmenorrhea .

Eligibility criteria:
inclusion criteria: 1. all young females have primary dysmenorrhea and idiopathic scoliosis. 2. they are diagnosed with idiopathic scoliosis; their trunk rotation and rib hump measured by scoliometer will be more than 5. 3. they will experience pain in abdominal region, back and/or referred to the thigh during menstruation. 4. they experience a regular menstrual cycle 5. their age will range from 18 to 25 years old. 6. body mass index (bmi) will range between 18.5 to 24.9 kg/m2. exclusion criteria: 1. females who have any pelvic diseases or secondary dysmenorrhea. 2. females who had received any spinal surgeries. 3. females with irregular menstrual cycles. 4. history of gynecological interventions and having received manipulative treatment within the 2 months before the beginning of the study.

Keywords: scoliosis , dysmenorrhea, myofascial release, pre menstrual symptoms
clozapine and haematologic malignancies: observational and retrospective study using the who pharmacovigilance database

Conditions: Lymphoma; Leukemia

Summary: clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. this study investigates reports of lymphoma and leukaemias for clozapine in the world health organization's (who) global database of individual safety case reports (vigibase).

clozapine is responsible of a wide range of adverse side effects.the investigators use vigibase, the world health organization (who) database of individual safety case reports, to identify cases of haematologic malignancies following treatment with clozapine.

Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database of individual safety case reports to 03/05/2019 * adverse events reported were including the meddra terms: malignant lymphoma (smq), leukaemia (hlgt) * patients treated with at least one liable antipsychotic drug (atc class n05a) exclusion criteria: * chronology not compatible between the drug and the toxicity
training parents of children with adhd by mindfulness-based stress reduction for reducing stress

Conditions: Stress, Psychological

Summary: the study aimed at comparing the effects of 8-week mbsr programme intervention group with usual care group in reducing parental stress and improving quality of life of parents of children with adhd in chinese culture.

this study aimed at comparing the effects of 8-week mindfulness-based stress reduction (mbsr) intervention with usual care in improving the parental stress, quality of life, and the feasibility and acceptability of mbsr of parents of children with attention deficit hyperactivity disorder (adhd) in chinese context after the coronavirus disease pandemic. this study was designed as a pilot randomised controlled trial with single-blind repeated measures. by using convenience sampling, 36 parents of children with adhd were recruited from the parent resource centre of the salvation army (centre), a non-government organization in hong kong, between july to august 2022. centre staff invited parents of children aged 3-12 diagnosed with adhd who can communicate and understand cantonese to participate. parents who had physical or severe intellectual disabilities, mental disorders or received any form of psychological intervention or psychiatric services were excluded from this study. all eligible parents were randomized to either the intervention group (n=18) or the usual care group (control) (n=18). parents assigned to the intervention group received the mbsr programme and usual services from the centre. mbsr had eight weekly sessions of 2.5 hours each, plus a whole day retreat in small groups between session 6 and 7. the usual care group remained with usual support from the centre, with interest activities such as cooking classes or calligraphy classes, but without any other form of intervention during this period.

Eligibility criteria:
inclusion criteria: * parents who have a child aged 3-12 with a confirmed diagnosis of adhd with or without medications * able to communicate and understand cantonese exclusion criteria: * having physical disabilities or severe intellectual impairments * any forms of mental disorders * receiving any other form of psychological intervention, behavioural treatment, or psychiatric services

Keywords: mindfulness-based stress reduction, parental stress, attention-deficit hyperactivity disorder adhd parent